FDA requests market withdrawal of weight-loss drug Belviq
After clinical trials showed an increased risk of cancer in patients taking Belviq, the FDA has recommended the withdrawal of the drug from the US market.
The US Food and Drug Administration (FDA) has announced their recommendation that Eisai Inc., the makers of weight-loss medication Belviq and Belviq XR (lorcaserin), voluntarily withdraw their product from the pharmaceutical market. The decision comes after an FDA review of the full clinical trial results shows that the potential risk of cancer associated with the drug outweighs the benefit of treatment.
The FDA approved Belviq in 2012 as an adjunct therapy to a reduced-calorie diet and increased physical activity for chronic weight management among adults who were obese or overweight with at least one weight-related comorbidity. At that time, the agency required the drug manufacturer to conduct a randomised, double-blind, placebo-controlled clinical trial to evaluate the risk of cardiovascular disease. The FDA’s review of safety data from the trial found that more patients taking the medication were diagnosed with cancer compared to those taking a placebo (7.7 versus 7.1 percent, respectively).
According to the regulatory body, the company has submitted a request to voluntarily withdraw Belviq.
The FDA has advised healthcare professionals to stop prescribing and dispensing both versions of Belviq. Patients have been told to stop using the medications and talk to healthcare professionals about other treatment options for weight loss.
“The FDA is not recommending special screening for patients who have taken Belviq. Standard screening recommendations for cancer should be implemented for any patient, regardless of prior Belviq treatment,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a statement.
“We will continue to track safety issues with medications on the market and use science and data as our guide to act quickly when we have determined that the risks associated with drugs are greater than the benefits of treatment,” said Woodcock.